high purity process piping: harmonization of asme codes

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1 PHARMACEUTICAL ENGINEERING MARCH/APRIL 2014 facilities and equipment Regulatory Harmonization High Purity Process Piping: Harmonization of ASME Codes and Standards by Barbara Henon, Vince Molina, Richard Campbell, and William Huitt This article presents interactions between the ASME Bioprocessing Equipment (BPE) Standard and ASME B31.3 Process Piping Code Committees following the addition of Chapter X High Purity Piping to the 2010 Edition of B31.3. This collaboration of ASME Committees will help to assure both safety and cleanability of high purity piping systems. F ollowing the introduction of the ASME Bioprocessing Equipment (BPE) Standard in 1997, most new pharmaceutical and biotechnology plants around the world have been constructed using the ASME BPE Standard. 1,2 The original scope of this standard, as approved in 1989 by the ASME Council on Codes and Standards stated: “This standard is intended for design, materials, con- struction, inspection, and testing of vessels, piping, and related accessories…for use in the biopharmaceutical industry.” The ASME B31.3 Process Piping Code also includes piping in pharmaceutical plants as being within its scope. 3 The BPE Standard references ASME B31.3, but there are inherent differences between the two ASME documents that have only recently been addressed. While the focus of the Code is primarily on safety issues, the 2010 Edition of ASME B31.3 introduced a new chapter, Chapter X High Purity Piping. Chapter X covers piping in high purity industries including the semiconductor and bioprocessing industries that have a particular need for cleanness and/or cleanability of their piping systems, but also must meet the safety requirements of the Code. Although the ASME B31.3 Code and the ASME BPE Standard have been developed independently, it is impor- WDQW JRLQJ IRUZDUG WKDW WKH\ GR QRW FRQWUDGLFW RU FRQÀLFW with one another. The addition of Chapter X is an essential ¿UVW VWHS LQ FORVLQJ WKH JDS EHWZHHQ WKH UHTXLUHPHQWV DQG intent of the ASME BPE Standard and the Code. Even before the publication of Chapter X, members of both ASME Com- mittees have been working together to harmonize the two ASME documents for which the latest editions of both are 2012. High Purity Piping The need for a chapter in the ASME Process Piping Code to address high purity concerns became apparent in 2004 when an engineer and a member of the B31.3 Code Commit- WHH VWDUWHG WR ZULWH D VSHFL¿FDWLRQ IRU DQ 8OWUD+LJK 3XULW\ 8+3 SLSLQJ LQVWDOODWLRQ XVLQJ WKH $60( % &RGH +H found that process piping systems typically used in semicon- ductor plants were not adequately addressed in the Code. 7KLV ZDV WKH FDVH HYHQ WKRXJK WKH &RGH LGHQWL¿HV SLSLQJ in semiconductor plants as within the intended scope. The semiconductor industry uses standards written by Semicon- ductor Equipment and Materials International (SEMI) that reference ASME B31.3. 4,5 The emphasis of the SEMI stan- dards is on cleanness rather than the basic safety consider- ations of ASME B31.3. Reprinted from PHARMACEUTICAL ENGINEERING THE OFFICIAL TECHNICAL MAGAZINE OF ISPE MARCH/APRIL 2014, VOL 34, NO 2 ©Copyright ISPE 2014 www.PharmaceuticalEngineering.org

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Page 1: High Purity Process Piping: Harmonization of ASME Codes

1PHARMACEUTICAL ENGINEERING MARCH/APRIL 2014

facilities and equipmentRegulatory Harmonization

High Purity Process Piping: Harmonization of ASME Codes

and Standardsby Barbara Henon, Vince Molina, Richard Campbell, and William Huitt

This article presents interactions between the ASME Bioprocessing Equipment (BPE) Standard and ASME B31.3 Process Piping Code

Committees following the addition of Chapter X High Purity Piping to the 2010 Edition of B31.3. This collaboration of ASME Committees will help to

assure both safety and cleanability of high purity piping systems.

F ollowing the introduction of the ASME

Bioprocessing Equipment (BPE) Standard

in 1997, most new pharmaceutical and

biotechnology plants around the world

have been constructed using the ASME

BPE Standard.1,2

The original scope of this

standard, as approved in 1989 by the ASME

Council on Codes and Standards stated:

“This standard is intended for design, materials, con-struction, inspection, and testing of vessels, piping, and related accessories…for use in the biopharmaceutical industry.”

The ASME B31.3 Process Piping Code also includes piping

in pharmaceutical plants as being within its scope.3 The BPE

Standard references ASME B31.3, but there are inherent

differences between the two ASME documents that have

only recently been addressed. While the focus of the Code is

primarily on safety issues, the 2010 Edition of ASME B31.3

introduced a new chapter, Chapter X High Purity Piping.

Chapter X covers piping in high purity industries including

the semiconductor and bioprocessing industries that have

a particular need for cleanness and/or cleanability of their

piping systems, but also must meet the safety requirements

of the Code.

Although the ASME B31.3 Code and the ASME BPE

Standard have been developed independently, it is impor-

WDQW�JRLQJ�IRUZDUG�WKDW�WKH\�GR�QRW�FRQWUDGLFW�RU�FRQÀLFW�with one another. The addition of Chapter X is an essential

¿UVW�VWHS�LQ�FORVLQJ�WKH�JDS�EHWZHHQ�WKH�UHTXLUHPHQWV�DQG�intent of the ASME BPE Standard and the Code. Even before

the publication of Chapter X, members of both ASME Com-

mittees have been working together to harmonize the two

ASME documents for which the latest editions of both are

2012.

High Purity PipingThe need for a chapter in the ASME Process Piping Code

to address high purity concerns became apparent in 2004

when an engineer and a member of the B31.3 Code Commit-

WHH�VWDUWHG�WR�ZULWH�D�VSHFL¿FDWLRQ�IRU�DQ�8OWUD�+LJK�3XULW\��8+3��SLSLQJ�LQVWDOODWLRQ�XVLQJ�WKH�$60(�%�����&RGH��+H�found that process piping systems typically used in semicon-

ductor plants were not adequately addressed in the Code.

7KLV�ZDV�WKH�FDVH�HYHQ�WKRXJK�WKH�&RGH�LGHQWL¿HV�SLSLQJ�in semiconductor plants as within the intended scope. The

semiconductor industry uses standards written by Semicon-

ductor Equipment and Materials International (SEMI) that

reference ASME B31.3.4,5

The emphasis of the SEMI stan-

dards is on cleanness rather than the basic safety consider-

ations of ASME B31.3.

Reprinted fromPHARMACEUTICAL ENGINEERINGTHE OFFICIAL TECHNICAL MAGAZINE OF ISPE

MARCH/APRIL 2014, VOL 34, NO 2©Copyright ISPE 2014

www.PharmaceuticalEngineering.org

Page 2: High Purity Process Piping: Harmonization of ASME Codes

2 MARCH/APRIL 2014 PHARMACEUTICAL ENGINEERING

facilities and equipmentRegulatory Harmonization

Semiconductor industry practices are based on the

UHTXLUHPHQWV�RI�IDEULFDWLRQ�IDFLOLWLHV�IRU�8+3�ÀXLGV�WKDW�DUH�used in the process tools.

6�$FKLHYLQJ�8+3�OHYHOV�RI�FOHDQQHVV�in fabrication of process gas lines was necessary in order

to increase the yield of semiconductor integrated circuits.7

Gas storage and delivery systems must not add impurities

WR�WKH�ÀXLGV�WKDW�W\SLFDOO\�UDQJH�LQ�SXULW\�IURP����������WR������������IRU�FKHPLFDO�DQG�SDUWLFXODWH�FRQWDPLQDQWV��These gases may be highly toxic, pyrophoric (spontaneously

FRPEXVWLEOH�LQ�DLU��RU�FRUURVLYH��0DMRU�DGYDQFHV�LQ�ÀXLG�handling and fabrication technology were essential to meet

the demands for both purity and safety.

Orbital Welding TechnologyIn the 1980s and 1990s, fabricators in the semiconductor

industry began using autogenous orbital Gas Tungsten Arc

Welding (GTAW) for joining process gas lines because the

smooth inner weld bead resulted in cleaner systems than

could be achieved with manual welding. Orbital welding

was part of the drive to reduce particulate contamination to

very low levels. Welds that are fully penetrated to the Inside

Diameter (ID) surface with a smooth inner weld bead are

far less likely to entrap particulates than the manual socket

welds that were previously used, and cleaner systems were

essential to achieving higher product yields.

� 8OWUD�+LJK�3XULW\��8+3��DQG�+LJK�3XULW\��+3��VHPL-conductor piping installations use mostly small diameter

Type 316L stainless steel tube, 0.250 inch, 0.375 inch, and

0.500 inch Outside Diameter (OD) rather than pipe. Tube

is more suitable than pipe for high purity applications since

it is manufactured with tighter dimensional tolerances than

pipe, thus increasing the repeatability of automatic welds.

Fittings, valves, and other components for semiconductor

V\VWHPV�DUH�KLJKO\�VSHFL¿F�WR�WKH�W\SH�RI�DSSOLFDWLRQ� Piping systems in other industries covered in the ASME

B31.3 Code include piping typically found in petroleum re-

¿QHULHV��FKHPLFDO��WH[WLOH��DQG�SDSHU�SODQWV�WKDW��IRU�WKH�PRVW�part, consist of metallic pipe installed with multipass manual

ZHOGV�ZLWK�¿OOHU�PHWDO�DGGHG�WR�WKH�ZHOG��2UELWDO�ZHOGV�RQ�WXELQJ�DUH�W\SLFDOO\�VLQJOH�SDVV�ZHOGV�ZLWK�D�ÀDW�RU�VOLJKWO\�FRQFDYH�2'�SUR¿OH��1HLWKHU�DXWRPDWLF�RUELWDO�ZHOGLQJ�QRU�helium mass spectrometer leak testing, commonly used for

testing of semiconductor process gas lines, had been ad-

dressed by the ASME B31.3 Code prior to the 2010 Edition.

Weld Coupon ExaminationThe semiconductor industry uses a different type of weld

examination from those previously listed in the ASME B31.3

Code. Because of the repeatability of orbital welding and

the impracticality of radiographic (or ultrasonic) examina-

tion on small diameter, thin-wall tubing, the semiconductor

industry uses a quality assurance system of weld coupon examination in which sample welds are made prior to and

GXULQJ�SURGXFWLRQ�DW�VSHFL¿HG�WLPHV�VXFK�DV�WKH�EHJLQQLQJ�and end of each shift, and after a change of power supply or

purge gas source, etc. The weld coupons are sectioned (cut

open) and examined visually for full penetration, discol-

RUDWLRQ��DOLJQPHQW��FUDFNLQJ��SRURVLW\�DQG�RWKHU�VSHFL¿HG�defects. If a defect is found, previous welds are cut out and

production welds discontinued until the weld problem has

EHHQ�LGHQWL¿HG�DQG�HOLPLQDWHG�

ASME Bioprocessing Equipment (BPE) StandardIn the mid 1980s, mechanical contractors in the emerg-

ing bioprocessing industry began to use the same fabrica-

tion technology as the semiconductor industry. Repeatable

smooth welds are essential to assure the cleanability of

bioprocess tubing systems to limit or minimize the growth of

microorganisms in bioengineered pharmaceutical products.

The initial impetus that eventually led to the development

of the ASME Bioprocessing Equipment (BPE) Standard was

bioprocessing equipment imported from Europe that had

manual welds that did not meet the quality standards that

ZHUH�URXWLQHO\�DFKLHYHG�E\�LQVWDOOHUV�LQ�WKH�8QLWHG�6WDWHV�using orbital welding equipment.

Volunteers working on the ASME BPE Standard commit-

tee have helped to systematize the installation of biopharma-

ceutical process tubing. The Subcommittee on Dimensions

DQG�7ROHUDQFHV�VSHFL¿HG�FRQWUROOHG�PDWHULDO�FKHPLVWU\��especially sulfur, to minimize heat-to-heat variability in

WKH�ZHOGDELOLW\�RI�WXELQJ�DQG�¿WWLQJV�PDGH�IURP�7\SH����/�stainless steel (and other austenitic stainless steels) and by

VWDQGDUGL]LQJ�WKH�GLPHQVLRQV�RI�ZHOG�HQGV�RQ�¿WWLQJV�DQG�other process components to be orbitally welded.

The Subcommittee on Surface Finish set standards for

smoothness of product contact surfaces while the Materials

Joining (MJ) Subcommittee established weld criteria for prod-

uct and non-product contact surfaces of orbital tube welds.

Acceptance criteria for welds on tubing systems do not allow

cracks, lack of fusion, incomplete penetration, porosity open

to the surface, inclusions open to the surface nor undercut.

Systems made from nominal diameter pipe are seldom used

for the higher purity requirements in the biopharmaceutical

industry. If they are used, the welds are made in accordance

with ASME B31.3 Table 341.3.2 with additional acceptance

criteria of the ASME BPE Standard in which cracks, lack-of-

fusion and incomplete penetration are prohibited.

The MJ Subcommittee also established methods of weld

examination and inspection that are not used routinely in

other industries. The ASME BPE Standard requires visual

H[DPLQDWLRQ�RI�WKH�RXWVLGH�GLDPHWHU�VXUIDFH�RI������RI�WXEH�welds and the use of borescopic or direct visual examination

WR�YLHZ�WKH�,'�RI�����RI�WKH�WXEH�ZHOGV��%3(�UHTXLUHV�VDPSOH�welds or coupons be performed prior to production welding

DQG�DW�VSHFL¿HG�WLPHV��:HOG�ORJV�DQG�ZHOG�FRXSRQ�ORJV�DUH�

Page 3: High Purity Process Piping: Harmonization of ASME Codes

3PHARMACEUTICAL ENGINEERING MARCH/APRIL 2014

facilities and equipmentRegulatory Harmonization

part of quality assurance with every weld numbered, docu-

PHQWHG�DQG�LGHQWL¿HG�RQ�DQ�LVRPHWULF�GUDZLQJ�RU�ZHOG�PDS��The ASME BPE is now an International Standard used in 30

countries. The application of the ASME BPE Standard has re-

VXOWHG�LQ�YHU\�HI¿FLHQW�LQVWDOODWLRQV�RI�ODUJH�VFDOH�ELRWHFKQRO-ogy facilities such as Amgen, Eli Lilly, Genentech, and others

that may have orbital welds numbering in the 30,000s.8

ASME B31.3 Chapter X High Purity PipingA presentation was made to the ASME B31.3 Section Com-

mittee in 2005 to point out the gaps in the Code with regard

WR�8+3�SUHVVXUH�SLSLQJ��3HUPLVVLRQ�ZDV�REWDLQHG�IURP�the ASME to begin writing a new Chapter for ASME B31.3.

$Q�8OWUD�+LJK�3XULW\�3LSLQJ�7DVN�*URXS��6XEJURXS�+��was formed to examine differences in piping requirements

between the practices in the semiconductor and the more

established industries covered by ASME B31.3. Since the

fabrication practices in the biopharmaceutical industry and

the semiconductor industry share commonalities, Subgroup

+�ZDV�H[SDQGHG�WR�LQFOXGH�LQGLYLGXDOV�KDYLQJ�H[SHUWLVH�LQ�the biopharmaceutical as well as semiconductor industry,

DQG�WKH�QDPH�ZDV�FKDQJHG�WR�6XEJURXS�+�+LJK�3XULW\�3LS-

ing in keeping with the broader scope.

� ,Q�ZULWLQJ�&KDSWHU�;��6XEJURXS�+�ZHQW�WKURXJK�WKH�HQWLUH�$60(�%�����&RGH�DQG�LGHQWL¿HG�HDFK�SDUDJUDSK�that applied to high purity piping and assembled those

paragraphs as well as new paragraphs into the new chapter.

3DUDJUDSKV�LQ�&KDSWHU�;�KDYH�WKH�SUH¿[�³8´�DV��SULRU�WR�SXEOLFDWLRQ��&KDSWHU�;�ZDV�FDOOHG�8OWUD�+LJK�3XULW\�3LSLQJ��6LQFH�WKH�WHUP�8OWUD�+LJK�3XULW\�UHIHUV�WR�WKH�PRVW�FULWL-FDO�OHYHO�RI�VHPLFRQGXFWRU�FOHDQOLQHVV�DQG�KDV�YHU\�VSHFL¿F�VHWV�RI�VWDQGDUGV�WKDW�GH¿QH�WKHVH�UHTXLUHPHQWV��WKH�QDPH�8+3�3LSLQJ�ZDV�ODWHU�FKDQJHG�WR�+LJK�3XULW\�3LSLQJ�VR�WKDW�Chapter X could be applied to a broader range of industries.

9

ASME B31.3 Fluid Services&KDSWHU�;�LQWURGXFHG�D�QHZ�ÀXLG�VHUYLFH�FDWHJRU\��+LJK�Purity Fluid Service, to the 2010 Edition of the Code. When

an owner designs a piping system to the ASME B31.3 Code,

LW�LV�KLV�UHVSRQVLELOLW\�WR�VHOHFW�DQ�DSSURSULDWH�ÀXLG�VHUYLFH�DV�GH¿QHG�E\�%������0HWDOOLF�SLSH�LQ�WKH�%�����%DVH�&RGH��&KDSWHUV�,�WR�9,��LV�W\SLFDOO\�LQ�1RUPDO�RU�&DWHJRU\�'�ÀXLG�service. Other chapters that were previously added to the

FRGH�KDYH�LQWURGXFHG�RWKHU�ÀXLG�VHUYLFH�FDWHJRULHV�VXFK�DV�&DWHJRU\�0�IRU�SLSLQJ�FDUU\LQJ�WR[LF�PDWHULDOV��DQG�+LJK�Pressure Fluid Service for piping systems designated by the

RZQHU�WR�EH�LQ�+LJK�3UHVVXUH�)OXLG�6HUYLFH��)LJXUH�0����Guide to Classifying Fluid Service�LV�D�ÀRZ�FKDUW�SURYLGHG�WR�KHOS�WKH�RZQHU�GHWHUPLQH�WKH�DSSURSULDWH�ÀXLG�VHUYLFH�IRU�his application.

� +LJK�3XULW\�)OXLG�6HUYLFH�LV�GH¿QHG�DV�³D�ÀXLG�VHUYLFH�that requires alternative methods of fabrication, inspection, examination, and testing not covered elsewhere in the Code,

with the intent to produce a controlled level of cleanness. 7KH�WHUP�WKXV�DSSOLHV�WR�SLSLQJ�V\VWHPV�GH¿QHG�IRU�RWKHU�purposes as high purity, ultra-high purity, hygienic, or aseptic.”� +LJK�3XULW\�)OXLG�6HUYLFH�FDQ�WKXV�LQFOXGH�8+3�DQG�+3�semiconductor process piping as well as hygienic bioprocess

piping or aseptic piping for food and diary applications.

Piping systems in the chemical processing industry that

may require a high level of cleanness or cleanability can be

declared high purity by the owner. The owner must declare

WKH�V\VWHP�WR�EH�LQ�+3�)OXLG�6HUYLFH�DQG�WKHQ�FRPSO\�ZLWK�all of the requirements of Chapter X.

10,11

Weld Coupon Examination in Lieu of 5% Radiography&KDSWHU�;�SDUDJUDSK�8��������SURYLGHV�IRU�Coupon Exami-nation of welds in lieu of�WKH�UHTXLUHG����UDQGRP�UDGLRJ-

raphy, ultrasonic, or in-process examination when orbital welding is used in fabrication. For the 2012 Edition of

&KDSWHU�;��SDUDJUDSK�8��������KDV�EHHQ�PRGL¿HG�WR�DOORZ�coupon examination when autogenous orbital welding is

used in fabrication or when a consumable insert is used in

conjunction with orbital welding.

Borescopic examination is now listed in Chapter X as an

approved method of visual examination of orbital welds.

This type of examination is effective in detecting both lack

of penetration and slight amounts of weld discoloration that

are not seen with radiography. Even slight amounts of weld

discoloration have been shown to reduce the corrosion re-

sistance of stainless steel and corrosion can have an adverse

affect on pharmaceutical products.12,13

ASME BPE Fittings Referenced in ASME B31.3,Q�DGGLWLRQ�WR�PHWDOOLF�DQG�QRQPHWDOOLF�IDFH�VHDO�¿WWLQJV�XVHG�in semiconductor process gas lines, ASME BPE orbital butt

ZHOG�¿WWLQJV�DQG�$60(�%3(�K\JLHQLF�FODPS�¿WWLQJV�WKDW�DUH�used for mechanical joints in biopharmaceutical applica-

tions, are now referenced in ASME B31.3.

� +\JLHQLF�FODPS�W\SH�¿WWLQJV�DUH�PHQWLRQHG�LQ�&KDSWHU�;�SDUDJUDSK�8������7XEH�)LWWLQJV�DQG�DOVR�KDYH�EHHQ�OLVWHG�LQ�$60(�%�����7DEOH�������&RPSRQHQW�6WDQGDUGV��1RWH�����RI�this table refers back to BPE “Part DT of ASME BPE covers dimensions and tolerances for stainless steel automatic ZHOGLQJ�DQG�K\JLHQLF�FODPS�WXEH�¿WWLQJV�DQG�SURFHVV�FRP-ponents.” In order to be listed, a component must be shown

to meet the requirements of ASME B31.3 for structural

integrity.

� 'UDZLQJV�RI�K\JLHQLF�FODPS�¿WWLQJV�DUH�VKRZQ�LQ�$60(�BPE-2012, Figure DT-2-1, and similarly in ASME B31.3-

������)LJXUH�8�������- Figure 1. These clamp assemblies

WKDW�DUH�XVHG�LQ�FRQMXQFWLRQ�ZLWK�VSHFL¿F�W\SHV�RI�JDVNHWV��DUH�TXLWH�GLIIHUHQW�IURP�WKH�W\SLFDO�ÀDQJHG�DQG�EROWHG�FRQ-

Page 4: High Purity Process Piping: Harmonization of ASME Codes

4 MARCH/APRIL 2014 PHARMACEUTICAL ENGINEERING

facilities and equipmentRegulatory Harmonization

nections used in normal ASME B31.3 piping systems.

In accordance with B31.3 each installed piping system

shall be tested to assure tightness. The test shall be a hydro-

static test in accordance with B31.3 para. 345.4 except as

otherwise provided. At the owner’s option, Chapter X has

added helium mass spectrometer testing which is common

in the semiconductor industry.

When a new term is added to an ASME Code or Standard,

D�GH¿QLWLRQ�PRUH�LQ�OLQH�ZLWK�LWV�LQWHQGHG�XVH�PXVW�EH�DGGHG�WR�WKH�OLVW�RI�GH¿QLWLRQV�LQ�WKDW�SXEOLFDWLRQ��'H¿QLWLRQV�ZHUH�added to ASME B31.3 paragraph 300.2 for orbital welding, IDFH�VHDO�¿WWLQJ��ZHOG�FRXSRQ��ZHOG�FRXSRQ�H[DPLQDWLRQ��and hygienic clamp joint�LQ�WKH������(GLWLRQ�DQG�D�GH¿QL-tion of autogenous welding was added in 2012.

Harmonization of ASME BPE and ASME B31.3,QWHUDFWLRQV�EHWZHHQ�$60(�%3(�DQG�%�����6XEJURXS�+�began in 2006 when a member of the ASME BPE Standards

Committee and the BPE Subcommittee on Materials Joining

(MJSC) attended an ASME B31.3 meeting in Atlanta, Geor-

JLD��7KH�&KDLU�DQG�DQRWKHU�PHPEHU�RI�WKH�6XEJURXS�+�VXE-

sequently were invited to attend the ASME BPE Materials

Joining Subcommittee (MJSC) meeting in Philadelphia in

2FWREHU������ZKHUH�WKH�6XEJURXS�+�PHPEHUV�PDGH�D�3RZ-

erPoint presentation to the MJSC. They stressed the ASME

B31.3 emphasis on safety comparing it to BPE’s concern with

cleanability and control of bioburden. At that meeting, the

0-6&�DSSRLQWHG�DQ�RI¿FLDO�OLDLVRQ�WR�LQWHUIDFH�EHWZHHQ�WKH�ASME BPE and ASME B31.3 Committees. Since then, liaison

reports have been made at meetings of both ASME commit-

tees. Other members of BPE have joined B31.3 Committees

and these volunteers have worked consistently to bring the

two ASME documents closer together.

Many members of the ASME B31.3 Committees were

unfamiliar with high purity piping and orbital welding so the

PHPEHUV�RI�6XEJURXS�+�RUJDQL]HG�D�3RZHU3RLQW�SUHVHQWD-

tion to the B31.3 Section Committee on this topic in Phoenix,

Arizona in 2010. At the same meeting, live demonstrations

of autogenous orbital welding were given for all the B31.3

VXEJURXSV��6DPSOHV�RI�WKH�W\SHV�RI�8+3�DQG�+3�¿WWLQJV��valves and clamps used in semiconductor and bioprocessing

systems, some of which have now been listed in Table 326 of

ASME B31.3, were on display.

ASME BPE/B31.3 Harmonization Task GroupKnowing that Chapter X was in preparation, the ASME BPE

Materials Joining Subcommittee formed a task group to

identify all of the references to ASME B31.3 in the ASME

BPE Standard to determine how these references might

be affected by the addition of Chapter X to the Code. The

+DUPRQL]DWLRQ�7DVN�*URXS�PHW�IRU�VHYHUDO�\HDUV�DW�%3(�meetings and reported their activities to ASME B31.3 Sub-

JURXS�+�DW�WKHLU�PHHWLQJV��7KH�WDVN�JURXS�IRXQG�D�WRWDO�RI�41 references to ASME B31.3 in the 2009 BPE Standard. As

a result, several references in Part MJ in the 2012 Edition of

%3(�UHIHU�WR�WKH�³DSSURSULDWH�ÀXLG�VHUYLFH´�ZKLFK�ZLOO�PRVW�OLNHO\�EH�+LJK�3XULW\�)OXLG�6HUYLFH�DV�GH¿QHG�LQ�WKH������Edition of ASME B31.3 for hygienic systems. References in

$60(�%3(�WR�VSHFL¿F�$60(�%�����SDUDJUDSK�QXPEHUV�ZHUH�changed to general references to ASME B31.3.

A statement was added to the General Requirements

section (Part GR-1) in the Scope of the 2012 Edition of the

ASME BPE Standard to alert users that for hygienic systems

LQ�ELRSURFHVVLQJ�SODQWV�WKH\�FRXOG�QRZ�VSHFLI\�+LJK�3XULW\�)OXLG�6HUYLFH�DV�GH¿QHG�LQ�$60(�%������$�EDOORW�ZDV�DS-

SURYHG�¿UVW�E\�WKH�0-6&�WKHQ�E\�WKH�%3(�6XEFRPPLWWHH�RQ�Figure 1. Typical clamp designs used in the biopharmaceutical industry.

Page 5: High Purity Process Piping: Harmonization of ASME Codes

5PHARMACEUTICAL ENGINEERING MARCH/APRIL 2014

facilities and equipmentRegulatory Harmonization

General Requirements (SCGR), but took several attempts

for approval by the ASME BPE Standards Committee. These

ASME Codes and Standards are by consensus so all com-

ments on the ballots must be answered and all negatives

resolved at each successive level of the record. This pro-

cess works surprisingly well and the negatives are usually

constructive with improved wording and clarity the typical

RXWFRPH��7KH�¿QDO��DSSURYHG�UHIHUHQFH�LQ�%3(�3DUW�*5���IRU�2012 is as follows:

“This Standard shall govern the design and construc-tion of piping systems for hygienic service. For process piping systems designed and constructed in accordance with ASME B31.3, it is the owner’s responsibility to select D�ÀXLG�VHUYLFH�FDWHJRU\�IRU�HDFK�ÀXLG�VHUYLFH��6KRXOG�DQ\�ÀXLG�VHUYLFH�PHHW�WKH�GH¿QLWLRQ�RI�KLJK�SXULW\�ÀXLG�Service (ASME B31.3, Chapter X) it is recommended that VXFK�ÀXLG�VHUYLFH�EH�VHOHFWHG�DQG�WKH�UHTXLUHPHQWV�RI�this Standard and ASME B31.3, Chapter X be met.”

This statement gives ASME BPE the authority to set stan-

dards for design and construction of hygienic systems and

when a piping (or tubing) system is to be used for hygienic

RU�KLJK�SXULW\�VHUYLFH�WKDW�PHHWV�WKH�GH¿QLWLRQ�RI�WKH�$60(�%�����+LJK�3XULW\�)OXLG�6HUYLFH��WKDW�ÀXLG�VHUYLFH�VKRXOG�be selected. Prior to the introduction of Chapter X, most of

WKHVH�V\VWHPV�ZHUH�FODVVL¿HG�DV�$60(�%�����1RUPDO�)OXLG�Service. The statement demands that the design and con-

struction requirements of both ASME BPE and ASME B31.3

EH�PHW��7KXV�LW�LV�HVVHQWLDO�WKDW�WKHUH�EH�QR�LQKHUHQW�FRQÀLFWV�between the two ASME documents.

Radiographic vs. Coupon ExaminationThe 2012 ASME BPE Standard (MJ-7.3.3) requires that “Ex-aminations shall be performed in accordance with the pro-YLVLRQV�RI�WKH�VSHFL¿HG�ÀXLG�VHUYLFH�LQ�$60(�%�����´ BPE

has never required radiographic examination of tube welds.

7KH�$60(�%3(�UHTXLUHPHQW�LV�IRU������YLVXDO�H[DPLQD-

tion of the outside diameter surfaces plus a minimum of

����UDQGRP�ERUHVFRSLF�H[DPLQDWLRQ�RI�WKH�LQVLGH�GLDPHWHU�RI�WXEH�ZHOGV�ZKLOH�WKH�$60(�%�����1RUPDO�)OXLG�6HUYLFH�UHTXLUHPHQW�LV�D�PLQLPXP�RI����YLVXDO�H[DPLQDWLRQ�DQG����random radiography or ultrasonic examination.

Because of the difference in these requirements, there

was always some vague concern that BPE requirements were

QRW�LQ�IXOO�FRPSOLDQFH�ZLWK�WKH�&RGH��+RZHYHU��SULRU�WR�WKH�introduction of Chapter X, users of BPE and B31.3 who did

QRW�VSHFLI\����UDGLRJUDSK\�ZHUH�QRW�QHFHVVDULO\�³YLRODWLQJ´�WKH�$60(�%�����&RGH�LI�WKH\�VSHFL¿HG�in-process examina-tion (B31.3 paragraph 344.7) instead of radiography.

� :LWK�WKH�QHZ�&KDSWHU�;�DQG�E\�VHOHFWLRQ�RI�+LJK�3XULW\�Fluid Service in ASME B31.3, users of ASME BPE can now

perform weld coupon examination in lieu of�WKH����UDGL-

ography or ultrasonic examination and be in undisputed

compliance with ASME B31.3.

� 7KH�UHTXLUHPHQW�IRU������YLVXDO�H[DPLQDWLRQ�RI�WKH�RXW-VLGH�VXUIDFH�DQG�����ERUHVFRSLF�H[DPLQDWLRQ�RI�WKH�LQVLGH�by ASME BPE is still in effect for welds in hygienic service

referencing the ASME BPE Standard. One could argue that

WKLV�LV�D�PRUH�VWULQJHQW�UHTXLUHPHQW�WKDQ�WKH����UDGLR-

graphic or ultrasonic examination required by ASME B31.3

1RUPDO�)OXLG�6HUYLFH�

How Weld Coupons are Made7KH�VHPLFRQGXFWRU�LQGXVWU\�KDV�GH¿QHG�UHTXLUHPHQWV�IRU�how weld coupons to be used for weld coupon examination

are made and examined. While weld coupons are made to

qualify welding procedures (WPS and PQR) and welding op-

erators (WOPQ) to ASME Sect. IX of the Boiler and Pressure

Vessel Code,14�DV�PRGL¿HG�E\�$60(�%������WKRVH�FRXSRQV�

are used to qualify a range of wall thicknesses, diameters

and alloys and may be performed long before construction

begins.

Primary weld coupons used for weld coupon examina-

tion are made prior to the start of production with sections

of tubing of the same alloy, diameter and wall thickness as is

being used in production to serve as a quality benchmark for

welds made during production. Production weld coupons are made during production to assure that the weld parame-

WHUV�IURP�WKH�TXDOL¿HG�ZHOGLQJ�SURFHGXUH��:36��DQG�RUELWDO�welding equipment continue to result in acceptable welds

throughout the installation.

The BPE Standard requires that sample (coupon) welds

EH�PDGH�DQG�H[DPLQHG�³RQ�D�UHJXODU�EDVLV´�WR�YHULI\�WKDW�the welding equipment is functioning properly and that the

,'�SXUJH�LV�VXI¿FLHQW�WR�SUHYHQW�ZHOG�GLVFRORUDWLRQ��0DQ\�installers using the BPE Standard make Bead on Pipe (BOP)

or Bead on Tube (BOT) welds which are made from a single

section of tubing without an actual joint. The members of

6XEJURXS�+�IHHO�WKDW�DQ�DFWXDO�MRLQW�LV�UHTXLUHG�IRU�ZHOG�coupons made during production, for the purpose of weld

coupon examination, to show that the end preparation and

¿W�XS�RI�ZHOG�FRPSRQHQWV�LV�JRRG�HQRXJK�WR�UHVXOW�LQ�SURSHU�joint alignment. This is consistent with the requirements for

in-process examination�DV�GH¿QHG�E\�$60(�%�����SDUD-

JUDSK�������ZKHUH�¿W�XS�DQG�MRLQW�DOLJQPHQW�RI�SURGXFWLRQ�welds are checked prior to welding. The next editions of BPE

and B31.3 will attempt to clarify and provide more consis-

tent requirements for weld coupons.

Method of ExaminationWhile the procedure for weld coupon examination in the

semiconductor industry requires the examiner to section or

cut open the coupon for visual examination as seen in Figure

2 top, coupon examination in bioprocess applications may

be an indirect visual examination using a borescope, or more

Page 6: High Purity Process Piping: Harmonization of ASME Codes

6 MARCH/APRIL 2014 PHARMACEUTICAL ENGINEERING

facilities and equipmentRegulatory Harmonization

likely, a direct visual examination as seen in Figure 2 bottom.

A member of ASME BPE MJSC proposed that borescopic

examination of coupon welds be allowed by ASME B31.3 in lieu of�VHFWLRQLQJ��7KLV�ZDV�DSSURYHG�¿UVW�DW�WKH�VXEFRPPLW-tee level and then by the ASME B31.3 Section Committee and

is in effect in the 2012 Edition of ASME B31.3.

Acceptance Criteria for Autogenous WeldsChapter X states that weld acceptance criteria for the refer-

encing code, e.g., ASME BPE or SEMI, shall apply, but welds

also must meet the acceptance criteria of ASME B31.3 para-

graph 341.3.2. Autogenous orbital welds on tubing generally

KDYH�D�ÀDW�2'�SUR¿OH��EXW�PD\�KDYH�VRPH�2'�FRQFDYLW\��especially on heavier wall thicknesses. The BPE Standard

makes some allowance for this for tube welds, but refers to

B31.3 for welds on pipe. Weld acceptance criteria for B31.3

are based on multipass welds on pipe with the addition of

¿OOHU�ZLUH�WR�WKH�ZHOG��DQG�ZKLOH�WKH\�GR�DGGUHVV�2'�DQG�,'�reinforcement, there is no mention of OD concavity. This is

generally interpreted to mean none allowed.

This issue was brought to the attention of the ASME

B31.3 Subgroup E, Fabrication, Examination and Testing.

This item, to permit some amount of OD concavity on welds

PDGH�ZLWKRXW�¿OOHU�PHWDO��LV�EHLQJ�HYDOXDWHG�IRU�LQFOXVLRQ�in the ASME B31.3 2014 Edition. If approved, this would

not only aid in the harmonization of ASME BPE and ASME

B31.3, but also will help to extend the use of Chapter X to in-

dustries11

other than biopharmaceutical that reference ASME

%�����DQG�FRXOG�EHQH¿W�IURP�WKH�DSSOLFDWLRQ�RI�DXWRJHQRXV�orbital welding of tubing but might not be able to meet the

current B31.3 weld acceptance criteria for OD concavity.

ASME BPE 2012 Edition7KH������(GLWLRQ�RI�WKH�%3(�6WDQGDUG�LV�WKH�¿UVW�HGLWLRQ�RI�%3(�WR�VSHFL¿FDOO\�UHIHUHQFH�WKH�QHZ�+LJK�3XULW\�)OXLG�Service and its associated Chapter X. This edition of BPE has

been completely reorganized since the 2009 edition. ASME

B31.3 does not address weld discoloration, but the BPE Ma-

terials Joining Part (Part MJ) has a new color chart showing

SHUPLVVLEOH�DQG�XQDFFHSWDEOH�OHYHOV�RI�ZHOG�+HDW�$IIHFWHG�=RQH��+$=��GLVFRORUDWLRQ�IRU�ZHOGV�RQ�HOHFWURSROLVKHG�DQG�mechanically polished 316L stainless steel tubing.

While welding destroys the passive layer and results in

some loss of corrosion resistance, the loss can be minimized

by proper inert gas purging during welding which limits the

amount of discoloration since the loss of corrosion resis-

tance increases with increasing amounts of discoloration.

� $FFHSWDQFH�OHYHOV�IRU�+$=�GLVFRORUDWLRQ�ZHUH�HVWDEOLVKHG�based on corrosion resistance in the ASTM G150 test and a

PRGL¿HG�$670�*���3RWHQWLRG\QDPLF�3RODUL]DWLRQ�&RUUR-

VLRQ�WHVW��$W�VLPLODU�OHYHOV�RI�+$=�GLVFRORUDWLRQ��WKH�FRU-rosion resistance of welds on electropolished tubing was

higher than that on mechanically polished tubing. The tech-

niques and oxygen levels used for the ID purge are detailed

LQ�1RQPDQGDWRU\�$SSHQGL[�0��3UHYLRXV�VWXGLHV�KDYH�VKRZQ�that while passivation can help to restore the passive layer

that is damaged by welding it cannot compensate for loss of

corrosion resistance caused by poor inert gas purging.12,13

ConclusionThe Scope of BPE 2012 has been broadened to say, “The ASME BPE Standard provides requirements for systems and components that are subject to cleaning and sanitation and/or sterilization including systems that are cleaned in place (CIP’d) and/or steamed in place (SIP’d) and/or other suitable processes.” The current scope should open up the BPE Standard to

RWKHU�KLJK�SXULW\�DSSOLFDWLRQV�WKDW�FDQ�EHQH¿W�IURP�IDEULFD-

tion technology including orbital welding of tubing systems,

specialized components, examination and testing methods

common to the semiconductor and bioprocess industries,

but not previously addressed by ASME B31.3.

Figure 2. Top: An orbital weld coupon sectioned for visual examination of the I.D. surface for the semiconductor industry. Bottom: An orbital weld coupon made for the biotechnology industry. For High Purity Fluid Service, the welds must meet the acceptance criteria of the referencing code, i.e. BPE or SEMI and also meet the criteria in ASME B31.3 Table 341.3.2.

Page 7: High Purity Process Piping: Harmonization of ASME Codes

7PHARMACEUTICAL ENGINEERING MARCH/APRIL 2014

facilities and equipmentRegulatory Harmonization

� %\�VSHFLI\LQJ�+LJK�3XULW\�)OXLG�6HUYLFH�DQG�XVLQJ�FRX-

SRQ�H[DPLQDWLRQ�RI�ZHOGV�LQ�OLHX�RI�WKH����UDGLRJUDSK\�RU�ultrasonic examination requirement of ASME B31.3, users

of ASME BPE can now be indisputably Code compliant, and

because the scope of BPE has been broadened, the use of

BPE should no longer be limited to use by the biopharma-

ceutical or bioprocessing industry.

There was close collaboration between members of ASME

BPE and ASME B31.3 during the development of Chapter X

that was published in 2010. This collaboration continued to

further implement changes that brought these documents

into closer alignment for the 2012 Editions and this work is

continuing for the 2014 Editions. This is a classic example

of how cooperation between volunteers from two different

ASME committees can work together to improve safety stan-

GDUGV�IRU�SLSLQJ�V\VWHPV�ZLWK�EHQH¿WV�WR�ERWK�LQGXVWU\�DQG�society.

At the Denver meeting of ASME B31.3 in September,

������WKH�$60(�DZDUGHG�HDFK�PHPEHU�RI�6XEJURXS�+�ZKR�had contributed to the writing of Chapter X with a &HUWL¿-cate of Excellence in appreciation for their work.

References1. ASME Bioprocessing Equipment (BPE) Standard.

American Society of Mechanical Engineers, Two Park

$YHQXH��1HZ�<RUN��1<���������������� +HQRQ��%�.���³�2UELWDO�:HOGLQJ�LQ�&RPSOLDQFH�ZLWK�WKH�

1HZ�$60(�%LRSURFHVVLQJ�(TXLSPHQW��%3(�������6WDQ-

GDUG�´�Pharmaceutical Engineering,�9RO������1R������������3KDUPDFHXWLFDO�(QJLQHHULQJ�$UWLFOH�RI�WKH�<HDU��ZZZ�pharmaceuticalengineering.org.

3. ASME B31.3 Process Piping Code. American Society of

0HFKDQLFDO�(QJLQHHUV��7ZR�3DUN�$YHQXH��1HZ�<RUN��1<�10016-5990.

4. SEMI F78 Practice for Gas Tungsten Arc (GTA) Welding

of Fluid Distribution Systems in Semiconductor Manu-

facturing Applications. Semiconductor Equipment and

Materials International (SEMI), San Jose, California

95134-2127.

��� 6(0,�)���6SHFL¿FDWLRQ�IRU�9LVXDO�,QVSHFWLRQ�DQG�$F-ceptance of Gas Tungsten Arc (GTA) Welds in Fluid

Distribution Systems in Semiconductor Manufacturing

Applications. Semiconductor Equipment and Materials

International (SEMI), San Jose, California 95134-2127.

��� +HQRQ��%�.��DQG�(��&RJKODQ��³�,QVWDOOLQJ�,%0�6HPLFRQ-

GXFWRU�3URFHVV�7RROV�DW�6DQGLD�1DWLRQDO�/DERUDWRU\�´�Micro, vol. 13 no. 8, 1995.

��� +HQRQ��%�.��DQG�-�6��2YHUWRQ��³'HVLJQ�3ODQQLQJ�IRU�&ODVV���8+3�6WDLQOHVV�6WHHO�3URFHVV�*DV�3LSLQJ�6\VWHP��3DUW�,�´�DQG�³&RQVWUXFWLQJ�D�&ODVV�,�8+3�3URFHVV�*DV�3LSLQJ�6\VWHP��3DUW�,,�´�Microcontamination, February/

March, 1988.

��� +HQRQ��%�.���6�(��0XHKOEHUJHU��DQG�*��'H3LHUUR��������³3URFHVV�3LSLQJ�±�$�&DVH�6WXG\�3DUW���±�2UELWDO�:HOGLQJ��:HOG�,QVSHFWLRQ��:HOG�'RFXPHQWDWLRQ��3DVVLYDWLRQ�´�Pharmaceutical Engineering,�9RO������1R�����������SS��86-94, www.pharmaceuticalengineering.org.

��� +HQRQ��%�.��DQG�'��&REE��³+LJK�3XULW\�3URFHVV�3LSLQJ��$GGLWLRQ�RI�&KDSWHU�;�+LJK�3XULW\�3LSLQJ�WR�WKH�$60(�%�����3URFHVV�3LSLQJ�&RGH�´�3UHVHQWHG�DW�WKH�ASME PVP-2012 Conference, Toronto, Canada, 2012.

����+XLWW��:�0���HW�DO���³1HZ�3LSLQJ�&RGH�IRU�+LJK±3XULW\�3URFHVVHV�´�Chemical Engineering, July, 2011, p. 49.

���� +XLWW��:�0���³&URVVRYHU�$SSOLFDWLRQV�IRU�WKH�$60(�%LR-

SURFHVVLQJ�(TXLSPHQW�6WDQGDUG�´�Chemical Engineer-ing, October 2010, p. 46.

�����.LPEUHO��.���³'HWHUPLQLQJ�$FFHSWDEOH�/HYHOV�RI�:HOG�Discoloration on Mechanically Polished and Electropol-

LVKHG�6WDLQOHVV�6WHHO�6XUIDFHV�´ Pharmaceutical Engi-neering,�9RO������1R�����������ZZZ�SKDUPDFHXWLFDOHQJL-neering.org.

�����*UDQW��$���%�.��+HQRQ��DQG�)��0DQVIHOG��³(IIHFWV�RI�Purge Gas Purity and Chelant Passivation on the Corro-

sion Resistance of Orbitally Welded 316L Stainless Steel

7XELQJ�±�3DUW�,�´�Pharmaceutical Engineering, Vol.

����1R����������SS���������³3DUW�,,�´�9RO������1R�����������www.pharmaceuticalengineering.org.

14. ASME Boiler and Pressure Vessel Code, Sect. IX, Ameri-

can Society of Mechanical Engineers, Two Park Avenue,

1HZ�<RUN��1<������������

About the AuthorsBarbara Henon is a graduate of Mt.

+RO\RNH�&ROOHJH��KDV�DQ�0$�LQ�]RRORJ\�IURP�&ROXPELD�8QLYHUVLW\��DQG�D�3K'�LQ�ELRORJLFDO�VFLHQFHV�IURP�WKH�8QLYHUVLW\�RI�Southern California. After postdoctoral

ZRUN�LQ�WKH�'LYLVLRQ�RI�1HXURVFLHQFHV�DW�WKH�%HFNPDQ�5HVHDUFK�,QVWLWXWH�DW�WKH�&LW\�RI�+RSH�LQ�Duarte, California, in 1984 she joined Arc Machines, Inc. in

3DFRLPD��&DOLIRUQLD��'U��+HQRQ�KHOSHG�WR�GHYHORS�WKH�$UF�Machines Training Department and wrote training manuals

for the orbital welding equipment manufactured by Arc Ma-

FKLQHV��,QF��1RZ�UHWLUHG�IURP�$UF�0DFKLQHV��VKH�UHSUHVHQWV�Magnatech LLC on the ASME B31.3 Committee. She is the

author of numerous articles including Pharmaceutical Engi-neering�$UWLFOH�RI�WKH�<HDU�LQ�������'U��+HQRQ�UHFHLYHG�WKH�American Welding Society (AWS) Image of Welding Award

LQ�WKH�,QGLYLGXDO�FDWHJRU\�LQ�������'U��+HQRQ�MRLQHG�WKH�ASME Bioprocessing Equipment (BPE) Committee in 1989

and served for two terms as Vice Chair of the BPE Standards

Committee. She is currently a member of the BPE Materials

Joining and Surface Finishes Subcommittees, the Subcom-

mittee on General Requirements and the Executive Com-

PLWWHH��8QWLO�WKLV�\HDU��VKH�ZDV�WKH�RI¿FLDO�/LDLVRQ�EHWZHHQ�

Page 8: High Purity Process Piping: Harmonization of ASME Codes

8 MARCH/APRIL 2014 PHARMACEUTICAL ENGINEERING

facilities and equipmentRegulatory Harmonization

the ASME BPE and ASME B31.3 Process Piping Commit-

WHH��7KLV�UROH�KDV�QRZ�EHHQ�DVVXPHG�E\�%LOO�+XLWW��6KH�LV�D�PHPEHU�RI�WKH�%�����6HFWLRQ�&RPPLWWHH�DQG�6XEJURXS�+�RQ�+LJK�3XULW\�3LSLQJ�WKDW�ZURWH�WKH�KLJK�SXULW\�FKDSWHU�RI�B31.3. She was a member of the Task Force that wrote the

SEMI F79 and F81 Standards for orbital welding in the semi-

conductor industry. She also serves on the AWS D10 Com-

mittees and AWS D18 Committees. She can be contacted by

telephone: +1-206-546-5518 or email: [email protected].

R.C. International, LLC, P.O. Box 60182, Seattle, Wash-

LQJWRQ��������86$�

Vince Molina is a Project Engineering

Manager at Air Products and Chemicals,

Inc. responsible for managing engineering

interface with third party EPC contrac-

tors during the execution of Air Products

SURMHFWV�JOREDOO\��+H�KDV�EHHQ�LQYROYHG�in piping engineering, design, and construction since 1990

across various industries including nuclear power, petro-

OHXP�UH¿QLQJ��FKHPLFDO��SHWURFKHPLFDO��SKDUPDFHXWLFDO��DQG�VHPLFRQGXFWRU��+H�KDV�EHHQ�D�PHPEHU�RI�$60(�%�����Section Committee since 1992, started as a member of Sub-

group A on General Requirements. Molina is currently the

&KDLU�RI�6XEJURXS�+�RQ�+LJK�3XULW\�3LSLQJ�ZKLFK�KH�RUJD-

nized in 2005 to start the development of the new Chapter X

WKDW�ZDV�¿UVW�SXEOLVKHG�LQ�WKH�$60(�%����������HGLWLRQ��+H�can be contacted by telephone: +1-909-447-3976 or email:

[email protected].

Richard Campbell is a Bechtel Fellow

and Welding Technical Specialist with

Bechtel Corporation. With a BS degree in

welding engineering from Le Tourneau

8QLYHUVLW\�DQG�D�3K'�LQ�PDWHULDOV�HQJL-neering from RPI, he has worked for 35

\HDUV�LQ�WKH�ZHOGLQJ�LQGXVWU\��+LV�ZRUN�LQ�WKH�KLJK�SXULW\�industries has spanned more than 15 years and includes

RZQLQJ�D�ZHOGLQJ�IDEULFDWLRQ�VKRS��D�SLSH¿WWLQJ�XQLRQ�VKRS��DQG�DV�DQ�RI¿FHU�ZLWK�3XULW\�6\VWHPV��,QF��D�WKLUG�SDUW\�LQ-

spection company. Dr. Campbell has been an active partici-

pant of the ASME Bioprocessing Equipment (BPE) Standard

FRPPLWWHH�IRU�PRUH�WKDQ����\HDUV��+H�QRZ�VHUYHV�DV�&KDLU�of the Materials Joining Subcommittee, responsible for

ZHOGLQJ�DQG�LQVSHFWLRQ�UHTXLUHPHQWV��+H�LV�DOVR�D�PHPEHU�of the BPE Standards Committee, Executive Committee, plus

several other BPE subcommittees, including the Metallic

0DWHULDOV�6XEFRPPLWWHH�DQG�ZDV�&KDLU�RI�WKH�%3(�&HUWL¿FD-

WLRQ�6XEFRPPLWWHH�IRU�QLQH�\HDUV��+H�LV�DOVR�9LFH�&KDLU�RI�the ASME B31.3 Subgroup E on Fabrication, Examination,

and Testing, and is a member of the ASME B31.3 Process

Piping Code Section Committee and the ASME B31 Fabrica-

WLRQ�DQG�([DPLQDWLRQ�&RPPLWWHH��+H�DOVR�VHUYHV�RQ�QXPHU-ous AWS codes and standards committees, including the

AWS D18 Welding in Sanitary Applications Committee for

WKH�IRRG�DQG�GDLU\�LQGXVWU\��+H�LV�DOVR�&KDLU�RI�WKH�$:6�&�&�Gas Tungsten Arc Welding Subcommittee. Dr. Campbell is

author of more than 20 articles. As an expert in stainless

steel welding, he authored AWS’s The Professional’s Advi-

VRU�RQ�:HOGLQJ�RI�6WDLQOHVV�6WHHOV��+H�FDQ�EH�FRQWDFWHG�E\�email: [email protected].

William (Bill) Huitt is President W.

0��+XLWW�&R��+H�KDV�EHHQ�LQYROYHG�LQ�industrial piping design, engineering and

construction since 1965. Positions have

included design engineer, piping design

instructor, project engineer, project super-

visor, piping department supervisor, engineering manager

DQG�SUHVLGHQW�RI�:��0��+XLWW�&R��+LV�H[SHULHQFH�FRYHUV�ERWK�WKH�HQJLQHHULQJ�DQG�FRQVWUXFWLRQ�¿HOGV�DQG�FURVVHV�LQGXVWU\�OLQHV�WR�LQFOXGH�SHWUROHXP�UH¿QLQJ��FKHPLFDO��SHWURFKHPLFDO��pharmaceutical, pulp and paper, nuclear power, biofuel, and

FRDO�JDVL¿FDWLRQ��+H�KDV�ZULWWHQ�QXPHURXV�VSHFL¿FDWLRQV��guidelines, papers, and magazine articles on the topic of pipe

GHVLJQ�DQG�HQJLQHHULQJ��+XLWW�LV�D�PHPEHU�RI�,63(�ZKHUH�KH�was a member of the Task Group on ISPE Water and Steam

6\VWHPV�±�%DVHOLQH�*XLGH�&KDSWHU����5RXJH�DQG�6WDLQ-

OHVV�6WHHO��&6,��&RQVWUXFWLRQ�6SHFL¿FDWLRQV�,QVWLWXWH��DQG�$60(��$PHULFDQ�6RFLHW\�RI�0HFKDQLFDO�(QJLQHHUV���+H�LV�D�PHPEHU�RI�WKH�%�����6HFWLRQ�&RPPLWWHH�DQG�6XEJURXS�+�RQ�+LJK�3XULW\�3LSLQJ��D�PHPEHU�RI�WKUHH�$60(�%3(�VXEFRP-

mittees and several Task Groups as well as the ASME Board

RQ�&RQIRUPLW\�$VVHVVPHQW�IRU�%3(�&HUWL¿FDWLRQ�ZKHUH�KH�VHUYHV�DV�9LFH�&KDLU��+XLWW�LV�DOVR�D�PHPEHU�RI�WKH�$PHUL-can Petroleum Institute Task Group for RP-2611, he serves

DGGLWLRQDOO\�RQ�WZR�FRUSRUDWH�VSHFL¿FDWLRQ�UHYLHZ�ERDUGV��and was on the Advisory Board for ChemInnovations 2010

DQG������D�PXOWL�LQGXVWU\�&RQIHUHQFH�DQG�([SRVLWLRQ��+H�can be contacted by telephone: +1-314-966-8919 or email:

[email protected].

� :�0��+XLWW�&R���3�2��%R[��������6W��/RXLV��0LVVRXUL�������������86$�